NCT02037620

Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

We propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular and respiratory function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment.

Detailed description

We will enroll 4 research participants who have sustained a motor complete SCI to participate in the proposed experiments. Participants will be screened for eligibility, followed by 80 days of usual care, epidural implantation, 80 days of cardiovascular epidural stimulation training, 80 days of voluntary movement (VM) epidural stimulation training and finally 80 days of stand epidural stimulation training. These interventions are done in sequential order, however they are cumulative. In between each intervention, participants will undergo motor and cardiovascular experiments and assessments.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	5-6-5 Specify electrode
DEVICE	Restore Advance Pulse Generator

Timeline

• Start date: 2014-07-01
• Primary completion: 2019-09-20
• Completion: 2019-09-20
• First posted: 2014-01-16
• Last updated: 2022-03-28
• Results posted: 2022-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study